Am Open-Label Phase II Study of the Safety and Efficacy of Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma

Trial Information

Am Open-Label Phase II Study of the Safety and Efficacy of Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma

- Participants will begin taking the study medication in the clinic on Cycle 1 day 1.
Each treatment cycle lasts three weeks. They will take the lenalidomide (capsules)
every day for the first two weeks only (days 1-14). They will take dexamethasone
(tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and will come to the outpatient treatment
center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle
is a rest period and the participant will not be taking any study medication.

- It is expected that participants will complete at least 8 cycles of the study, which
adds up to 168 days. If the participant completes the first 8 cycles, has stable or
responding disease and has not experienced bad side effects, they will be allowed to
continue treatment on a maintenance schedule, detailed in the protocol, at the study
doctor's discretion.

Inclusion Criteria:

- Diagnosis of multiple myeloma based on standard diagnostic criteria or by the new
International Myeloma Foundation 2003 Diagnostic Criteria

- Relapsed or relapsed and refractory disease after receiving between 1 and 3 prior
regimens

- Negative serum or urine pregnancy test

- Age 18 years or older

- Karnofsky performance status of 60 or greater

Exclusion Criteria:

- Grade 2 or greater peripheral neuropathy within 14 days before enrollment

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